On a roll, Takeda's dengue vaccine shifts into FDA's fast review lane

Three months after gaining its first worldwide approval, from Indonesia, for its dengue fever vaccine, Takeda is progressing toward a blessing from the FDA.

The Japanese company’s Qdenga (TAK-003) shot has received a priority review designation for its biologics license application. It will be evaluated for its ability to prevent dengue disease from any of the fever’s four serotypes in individuals ages 4 through 60.

Developing a dengue vaccine has been a decade-long pursuit for Takeda, which projects peak revenue potential to come in at between $700 million and $1.6 billion. 

Dengue has appeared in more than 125 countries and is one of the primary causes of hospitalization in children in many parts of the world. Sanofi was first with a vaccine for dengue. But its launch of Dengvaxia in the Philippines was derailed in 2017 when the company revealed that the shot could cause more serious dengue infection if given to patients who had never contracted the virus.

Dengvaxia was approved in the U.S. in May, 2019, but with tight restrictions. The shot is limited to those between ages 9 and 16 living in endemic areas who have laboratory-confirmed previous dengue infection.

Dengue is a mosquito-borne virus, which is a leading cause of fever among travelers to Latin America, the Caribbean and Southeast Asia, Takeda said. Of the 888 dengue infections in the U.S., 96% were the result of travel to dengue endemic areas, Takeda said.

Initial infection with dengue typically results in either no symptoms or a mild illness that can be mistaken for the flu or another viral infection. Subsequent infection can lead to severe dengue, including dengue hemorrhagic fever, a more severe form of the disease that can be fatal.

A study of Qdenga showed 80% efficacy at preventing symptomatic infection at 12 months and 90% efficacy at preventing hospitalizations at 18 months. The two-shot series showed the ability to provide protection for 4.5 years.

Indonesia remains the only country that has endorsed the vaccine. The company is pursuing sanction in other endemic countries. Last month, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended its use in Europe and dengue-endemic countries that participate in parallel with the EU’s regulatory procedures.

The final step in the path to approval in Europe is a marketing authorization decision from the European Medicines Agency, which is expected in the coming months, Takeda said.